FDA Recall D-0836-2016

Hospira Inc. · Lake Forest, IL

Class III Ongoing 3712 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

Product

Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02

Lot / code: Lot 52-045-EV, Exp 07/1/2016

Quantity: 103,600 vials

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.

Recall record

Recall number: D-0836-2016
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2016-03-15
Classified by FDA Center: 2016-05-04
FDA published: 2016-05-11
Recalling firm: Hospira Inc.
Firm location: Lake Forest, IL

Drug identification

Brand name(s): QUELICIN
Generic name(s): SUCCINYLCHOLINE CHLORIDE
Manufacturer(s): Hospira, Inc.
NDC(s): 0409-6629, 0409-6970
Route(s): INTRAMUSCULAR, INTRAVENOUS

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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